Active — Not RecruitingPhase 1/2

Bevacizumab and Pembrolizumab Combination in Platinum-resistant Recurrent/Metastatic NPC

Singapore48 participantsStarted 2019-05-01

Plain-language summary

This is a single center, randomized, phase Ib/II open-label study of pembrolizumab (pembro or MK-3475) with or without bevacizumab in patients with recurrent non-curable or metastatic nasopharyngeal carcinoma (NPC).

Who can participate

Age range21 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. The participant (or legally acceptable representative if applicable) provides written consent for the trial.
✓. Participants who are at least 21 years of age on the day of signing informed consent with histologically or cytologically confirmed diagnosis of non-keratinizing nasopharyngeal carcinoma (NPC) that has recurred at loco regional and/or distant sites will be enrolled in this study.
✓. Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
✓. Have locally or centrally determined EBV-positive NPC by EBV-encoded small RNA in situ hybridization (EBER in situ hybridization \[ISH\]) assay. If EBV-positive status has been previously determined by EBER ISH assay, then no re-testing is required. Note: If EBV status by EBER ISH assay has not been previously determined, tumor tissue from archival tissue may be submitted for EBV determination.
✓. Received one or more lines of chemotherapy, which must include prior treatment with a platinum agent and must not be amenable to potentially curative radiotherapy or surgery.
✓. Have provided archival tumor tissue sample of newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue. Note: If submitting unstained cut slides, newly cut slides should be submitted to the testing laboratory within 14 days from the date slides are cut.
✓. Willingness to donate blood and tissue for mandatory translational research studies.
✓. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion criteria

What they're measuring

Primary endpoint of ORR

Timeframe: 2 years

The secondary endpoint of PFS

Timeframe: 2 years

Progression free survival (PFS)

Timeframe: 2 years

Trial details

NCT IDNCT03813394

SponsorNational University Hospital, Singapore

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-31

View on ClinicalTrials.gov More Locally Recurrent Cancer trials

Who can participate

Age range21 Years – 99 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. The participant (or legally acceptable representative if applicable) provides written consent for the trial.
✓. Participants who are at least 21 years of age on the day of signing informed consent with histologically or cytologically confirmed diagnosis of non-keratinizing nasopharyngeal carcinoma (NPC) that has recurred at loco regional and/or distant sites will be enrolled in this study.
✓. Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
✓. Have locally or centrally determined EBV-positive NPC by EBV-encoded small RNA in situ hybridization (EBER in situ hybridization \[ISH\]) assay. If EBV-positive status has been previously determined by EBER ISH assay, then no re-testing is required. Note: If EBV status by EBER ISH assay has not been previously determined, tumor tissue from archival tissue may be submitted for EBV determination.
✓. Received one or more lines of chemotherapy, which must include prior treatment with a platinum agent and must not be amenable to potentially curative radiotherapy or surgery.
✓. Have provided archival tumor tissue sample of newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue. Note: If submitting unstained cut slides, newly cut slides should be submitted to the testing laboratory within 14 days from the date slides are cut.
✓. Willingness to donate blood and tissue for mandatory translational research studies.
✓. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1